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Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer

NCT05341583 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2024-08-23

No results posted yet for this study

Summary

This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.

Conditions

Interventions

DRUG

Ensartinib

Ensartinib 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.

DRUG

Placebo

Placebo 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-24
Primary Completion
2025-06-01
Completion
2025-07-23

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05341583 on ClinicalTrials.gov